Titan Gel Rep Cpk/Ldh Isoenzyme Control
FDA 510(k) K874141 · Helena Laboratories
510(k) numberK874141
Submission
- Device name
- Titan Gel Rep Cpk/Ldh Isoenzyme Control
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- October 13, 1987
- Decision date
- November 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Titan Gel Rep Cpk/Ldh Isoenzyme Control cleared by the FDA?
Titan Gel Rep Cpk/Ldh Isoenzyme Control (K874141) received a 510(k) decision of Substantially Equivalent on November 4, 1987, 22 days after the submission was received.
What is the product code of K874141?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.